Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction (NCT04801459) | Clinical Trial Compass
UnknownNot Applicable
Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction
China148 participantsStarted 2021-04-02
Plain-language summary
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\) Pathological examination confirmation the adenocarcinoma of stomach before surgery
* 2\) Physical conditions compliance with the requirements for curative gastrectomy
* 3\) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
* 4\) Comply with the protocol during the whole study period
* 5\) No neoadjuvant therapy administration
* 6\) Sign informed consent and permission of withdraw in the whole study period
* 7\) Consent to provide the tissue specimens after surgery for this study
* 8\) Estimation the overall survival after surgery no less than 6 months
* 9\) No anesthesia or operation contraindication disease
* 10\) cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations
* 11\) Negative cytological detection in operation
* 12\) No seriously concomitance's diseases
* 13\) Karnofsky Performance Scores (KPS) more than 60
* 14\) Examined lymph node count no less than 16
Exclusion Criteria:
* 1\) Women during pregnant stage and breast-feed stage
* 2\) Women of childbearing age without any contraceptive measures
* 3\) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
* 4\) Immunosuppressive therapists for organ transplantation
* 5\) Seriously uncontrolled recurrent infection
* 6\) other malignant tumors
* 7\) No abilities of self-knowledge or mental disorders
* 8\) Participating in other clinical trials
* 9\) Siewert I and II esophago…
What they're measuring
1
Early postoperative recovery results
Timeframe: Within 1 month after surgery
2
Late postoperative recovery results
Timeframe: 1 year after surgery
Trial details
NCT IDNCT04801459
SponsorTianjin Medical University Cancer Institute and Hospital